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Summary

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: "This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries." -BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Table of Contents

Preface to the First Edition

Preface to the Second Edition

About the Editors

Contributors

Overview of Pharmaceutical Medicine

The Practice and Practitioners of Pharmaceutical Medicine

Pharmaceutical Medicine as a Medical Specialty

Clinical Research Education and Training for Biopharmaceutical Staff

Drug Discovery and Development

Introduction

Drug Discovery: Design and Serendipity

Pharmaceutics

Non-clinical Toxicology

Informed Consent

Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure

Phase II and Phase III Clinical Studies

Phase IV Drug Development: Post-Marketing Studies

Site Management

Good Clinical Practices

Quality Assurance, Quality Control, and Audit

The Unique Role of Over-the-counter Medicine

Special Populations and Required Special Studies

Introduction

Drug Research in Older Patients

Drug Development Research in Women

Clinical Research in Children

Racial and Ethnic Issues in Drug Registration

Hepatic and Renal Failure

Drug Interactions

Orphan Drugs

Applied Aspects of Drug Development

Introduction

Biotechnology Products and Development

Pharmacoeconomics: Economic and Humanistic Outcomes

Pharmacoepidemiology and the Pharmaceutical Physician

Statistical Principles and Application in Biopharmaceutical Research

Data Management

Patient Compliance: Pharmionics, A New Discipline

Monitoring Drug Concentrations in Clinical Practice

Generics

Complementary Medicines

Drug Regulation

Introduction

United States Regulations

Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals

The Development of Human Medicines Control in Europe From Classical Times to the Year 2000